1. Field of Invention
The present invention relates to methods, devices, and computer generated models for a system of orthopedic surgery and more particularly for surgical employment of distraction osteogenesis using intra-oral omnidirectional distraction devices. This invention is implemented using medical imaging; medical modeling; computer-aided design and manufacturing; a novel craniofacial anatomic surgical simulator, a custom-fitted, removable fixation device with distractor; and, a precision docking mechanism that allows omnidirectional positioning of skeletal segments.
2. Description of the Related Art
In the past, computerization for surgical preplanning purposes has provided stereolithographic models of the anatomic site. These are three-dimensional models constructed using digitized information from scanning devices such as laser and acoustic reflection apparatus and various types of transmission apparatus including X-ray, magnetic resonance imaging (MRI), positron emission (PET or SPECT) as well as ultrasonic radiation.
Upon data being captured by scanning a series of spaced parallel planes, the scans are combinable by computed-tomographic (CT) techniques to construct a three dimensional projection of the scan in the form of a medical model such as a stereolithographic representation. Anatomical modeling using CT-scan data is well known and is widely accepted in pre-operative planning, rehearsal of surgical procedures, and the manufacture of prosthetic devices.
U.S. Pat. No. 6,112,109 of D'urso and U.S. Patent Application Publication 2005/0133955 both describe the use of CT-scan data for constructing prosthetic devices that are custom-fit to provide a better relationship between the remaining healthy bone and the orthopedic implant.
To implement the inventor's system of orthopedic surgery several heretofore unknown devices needed to be developed. A craniofacial anatomic surgical simulator is described, infra, for mounting and working the stereolithographic model. As background to this development, Krause et al. in U.S. Pat. No. 6,701,174 comment that in the complex area of bone distraction surgery “it is difficult, if not impossible, to make accurate surgical plans based solely on a limited number of two-dimensional renderings of bone geometry. This is because of the complex and inherently three-dimensional nature of bone deformities as well as of fixator geometry. Furthermore, two-dimensional depictions of surgical plans may not accurately portray the complexities involved in accessing the target positions of the osteotome and fixator pins surrounding the operated bone. Lack of three-dimensional modeling of these geometric complexities makes it difficult to accurately mount the fixator on the patient according to the presurgical plan”.
The computer-assisted preplanning of Krause et al. made an early attempt to resolve this long-felt need through the use of a Taylor Spatial Frame—a collection of fixator struts and associated software; however, they found that the apparatus did not provide visual feedback on how the fixator frame and bone fragments should be moved over time.
As further background to the surgical simulator hereof, in the medical literature Cheung et al. In a 2007 article entitled, Vector Guidance Splint for Internal Maxillary Distraction (IL Oral Maxillofacial Surgery, pp. 1852 et seq.) reports using a Hanau Engineering Articulator, developed in the 1920's.
Taking dental articulators as the forebears of the Craniofacial Anatomic Surgical Simulator hereof leads one to view the articulator patent art starting with Hanau, U.S. Pat. No. 1,586,739 and leading patents to Tradowsky, U.S. Pat. No. 4,365,955; El Hadary, U.S. Pat. No. 5,073,109; Federici, U.S. Pat. No. 5,533,896; and Shih, U.S. Pat. No. 5,720,612. None of these devices fulfill the simulation requirements of the disclosure at hand.